Comparison of Reduced Cuff-pressure of the Laryngeal Tube Under General Anesthesia (LTS)
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|ClinicalTrials.gov Identifier: NCT02300337|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : January 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Airway Morbidity||Device: Reduce Cuff pressure||Not Applicable|
The ventilation of both cuffs of the laryngeal tube by using the color coding of syringe and connector is a simple, fast and easy way to stabilize the tube and secure seal against the surrounding tissue.
The user of this method has only knowledge of the volume (ml), with which the cuff is vented, but not over the cuff pressure (cmH₂O) itself.
Permanently high pressures can cause to a lesions to necrosis in the adjacent tissue, on the other hand, the material of the bulging cuff fits less well the anatomy of the patient, leading to leaks in the breathing circuit.
Studies of pediatric anesthesia show that on 40cmH₂O reduces the volume of the leak in the laryngeal mask airway by reducing the cuff pressure and the ventilation is improved in sequence.
In the proposed study, the volume of leakage at the fill volume specified by the manufacturer (color coding), 60cmH₂O, 50cmH₂O, 40cmH₂O and 30cmH₂O to be captured.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of the Tightness of the Laryngeal Tube Under Mechanical Ventilation Before and After Reduction of Cuff Pressure on 60cmH₂O, 50cmH₂O, 40cmH₂O or 30cmH₂O|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Reduce Cuff Pressure
Cuff Pressure difference between inspiration and expiration is measured.
Device: Reduce Cuff pressure
We reduce the Cuff Pressure from the LTS-D (Laryngeal Tube suction) from 60 to 50 to 40 to 30cmH2O and measure the Delta from Inspiration to Expiration Tidalvolume (Delta Vt). The Delta Vt shows the actual leakage.
- Comparison of Leakage between the different Cuff Pressure [ Time Frame: < 5 Minutes ]We want to measure the tightness of the reduced Cuff Pressure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300337
|Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University|
|Mainz, Rhineland-Palatinate, Germany, D55131|
|Principal Investigator:||Rüdiger Noppens, MD||University JG, Mainz|